At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
Job Title : Senior Clinical Process Specialist
Job ID : 1709991
Job Description :
PURPOSE : Apply clinical research expertise to provide project related assistance across complex and multiple project(s), sites and project teams. Lead teams functionally, where assigned, including awareness of scope of work, budget, and resources. Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics. Mentor/ coach Clinical Process Associate/Specialist colleagues.
RESPONSIBILITIES :
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project timelines
- Establish and maintain effective project/ site communications
- Create and maintain relevant project documents/ trackers
- Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
- Review, evaluate and recommend modifications to designated processes
- Oversee and participate in document management (creation, review, maintenance, storage, as applicable)
- Participate in (study) team meetings and implement action items
- Collaborate with the project lead/team members in creation/review of study documents including Quality manuals
- Act as point of contact for assigned deliverables for specific customers or projects
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
- Escalate quality issues to relevant stakeholders and/or line manager.
- Coach junior clinical process associate/specialists
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements;
- i.e., ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Familiarity with related systems and software’s utilized in clinical operations.
- Strong written and verbal communication skills including good command of English language
- Results and detail-oriented approach to work delivery and output
- Good problem solving skills
- Good planning, time management and prioritization skills
- Ability to handle conflicting priorities
- Attention to detail and accuracy in work Good software and computer skills, including MS Office applications including but not limited to Microsoft Word, Excel and PowerPoint
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Strong leadership skills
- Ability to work across cultures and geographies with a high awareness and understanding of cultural differences
- Act as a mentor for Clinical Process Associate colleagues
Qualifications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree in life sciences or related field and min 4 years with relevant clinical research experience; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
- Extensive use of keyboard requiring repetitive motion of fingers.
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Regular sitting for extended periods of time.
- May require to work in shifts
- If you want to make an impact in the global research market, where we are working to make a real difference in patient health, we ask you to apply now and join our team.
